Position Title:Senior Clinical Trial Associate, Clinical Operations
Reports to: Senior Director, Clinical Operations
Status: Regular, Full-Time, Exempt
Location: San Francisco, CA
Assembly Biosciences (NASDAQ symbol ASMB) is a clinical-stage biotechnology company advancing two innovative platform programs: a Hepatitis B-Cure program consisting of a new class of oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and a novel class of oral synthetic live biotherapeutic candidates, which are designed to treat disorders associated with the Microbiome.
The HBV pipeline consists of a lead program in multiple global Phase 2a studies; a 2ndGeneration program entering Phase I late this year, and a 3rdprogram approaching clinical candidate selection. We expect this pipeline to represent a backbone therapy for increasing cures in HBV, and can be envisioned as a foundation of the company's research in virology globally.
The Microbiome platform consists of our lead programs in GI, partnered with Allergan, nearing the first IND/Phase Ib later this year and early next for Ulcerative Colitis, and a pipeline of other disease areas in consideration for advancement that are wholly owned by Assembly Biosciences.
The Company plans to move to the Oyster Point Area in South San Francisco by the end of 2018. As Assembly nears 100 employees, of which ~60 are based in San Francisco, it is anticipated that future growth will be focused at our new South San Francisco Location. The Company has a strong balance sheet having recently raised $166 million, bringing its cash reserves to approximately $250 million and thus positioned well to build the next phase of Assembly toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
The Senior Clinical Trial Associate of Clinical Operations will be responsible for mentoring junior CTAs, managing TMFs, managing in-house files, working on assignments that require judgment in prioritizing tasks, having an understanding of the implications of the work being performed, and being highly organized with the ability to multi-task and adjust direction based on changing project/corporate priorities.
Specific responsibilities include, but are not limited to:
Ensure compliance with protocol and overall objectives across all investigator sites
Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
Execute study activities according to study protocol, regulatory guidelines and operational plan
Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
Participate in study start-up, conduct and closeout activities
Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
Assemble and distribute study materials to clinical sites as needed
Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study- status trackers.
Maintain the Trial Master File for all clinical projects
Minimum 2 years relevant experience as a CTA in Clinical Operations
Excellent written and verbal communication skills
Strong PC skills (MS Word, MS Excel)
Sound analytical and problem-solving skills
Act with consistent sense of urgency with acute attention to detail
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
Exceptional organizational and time management skills
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Assembly Biosciences, Inc.